Mineralocorticoid Receptor Antagonism with Finerenone: A New Era in the Management of Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction.

Abstract

Finerenone is a novel nonsteroidal mineralocorticoid receptor (MR) antagonist (MRA) with unique pharmacological properties that offer potent and selective blockade of the MR with a more favorable side effect profile than spironolactone and eplerenone. In a large phase III clinical trial involving 13,026 patients with type 2 diabetes mellitus and a broad spectrum of chronic kidney disease, finerenone provoked a substantial placebo-subtracted reduction in the risk of hospitalization for heart failure (HF). These preliminary clinical trial data, along with the ongoing uncertainty about the safety and efficacy of MR antagonism in patients with HF and higher levels of ejection fraction have provided the rationale for the design of the FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure) trial. In this multicenter, double-blind, randomized, phase III trial involving 6001 patients with HF and mildly reduced or preserved ejection fraction, finerenone was superior to placebo in improving the primary composite outcome of total (first and recurrent) worsening HF events and death from cardiovascular causes. This benefit was similar in magnitude in patients receiving and in patients not receiving background treatment with a sodium-glucose co-transporter type 2 inhibitor, suggesting a potential additive benefit with combination therapy. We explore the emerging role of the nonsteroidal MRA finerenone as a new therapeutic opportunity to improve the risk of adverse cardiovascular outcomes in patients with HF and mildly reduced or preserved ejection fraction. We discuss preliminary clinical trial data and provide a critical evaluation of the main results of the FINEARTS-HF trial.